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Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects

NCT ID: NCT05887791

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-04-01

Brief Summary

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To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.

Detailed Description

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Conditions

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Healthy Prediabetic State

Keywords

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collagen peptides blood sugar modifying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Collagen hydrolysate dose 1

Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.

Group Type EXPERIMENTAL

Collagen hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Single dose

Collagen hydrolysate dose 2

Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.

Group Type EXPERIMENTAL

Collagen hydrolysate

Intervention Type DIETARY_SUPPLEMENT

Single dose

Placebo

Flavoured water

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose

Interventions

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Collagen hydrolysate

Single dose

Intervention Type DIETARY_SUPPLEMENT

Placebo

Single dose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is \< 5.7%) or Healthy normo-glycaemic subjects: fasting glucose \<100 mg/dL and HbA1c is \< 5.7%
* Age: 18-70 years
* Body mass index 19-35 kg/m2
* Current Non-smoker
* Signed informed consent form
* No changes in food habits or physical activity 3 months prior to screening and during the study
* If applicable, stable intake of chronic medication of at least 4 weeks

Exclusion Criteria

* Subjects with diagnosed Type 2 Diabetes mellitus with medical treatment
* Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) and absorption of nutrients
* Intake of medications known to affect glucose tolerance, e.g., diabetic medication, SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
* Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety
* Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST \>3 x ULN)
* Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
* Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
* Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids
* Drug-, alcohol- and medication abuses
* Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioTeSys GmbH

OTHER

Sponsor Role collaborator

Rousselot BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicoletta Virgilio, PhD

Role: STUDY_DIRECTOR

Rousselot BV

Locations

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BioTeSys GmbH

Esslingen am Neckar, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BTS1984/23

Identifier Type: -

Identifier Source: org_study_id